Omitting Nasogastric Tube Decompression in Minimally Invasive Pancreaticoduodenectomy

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Begins enrollment this month; Phase 2

Conditions: Nasogastric Tube Decompression; Minimally Invasive Surgical Procedures; Pancreaticoduodenectomy

Treatments: Procedure: Omission of nasogastric tube decompression; Procedure: nasogastric tube decompression

Study type: Interventional

Funder types: Other

Identifiers

NCT07370116

NCC2025C1365

Details and patient eligibility

About

This study will evaluate two perioperative nasogastric tube strategies in patients undergoing laparoscopic pancreatoduodenectomy. The goal is to determine whether routine omission of a nasogastric tube is not worse than routine nasogastric tube placement in terms of overall complications and postoperative recovery.

Participants will be randomly assigned to one of two groups. Each group will receive the assigned nasogastric tube strategy during and after surgery, and will be followed during the hospital stay and after discharge for up to postoperative 90 days. Information will be collected from routine clinical care, including discomfort score, symptoms, imaging or laboratory tests when clinically indicated, and postoperative outcomes.

The main outcome of this study is the overall burden of postoperative complications within 30 days after surgery, measured using the Comprehensive Complication Index, which summarizes all complications into a single score. Secondary outcomes include rates of pancreas surgery-specific complications (such as delayed gastric emptying, pancreatic fistula, bile leak, bleeding, and chyle leak), other abdominal and pulmonary complications, and organ dysfunction (including kidney injury, sepsis, and new cardiac dysfunction). The study will also evaluate patient discomfort related to the nasogastric tube (pain/discomfort scores), the need for nasogastric tube reinsertion, postoperative recovery milestones (ability to resume oral intake and length of hospital stay), healthcare costs, and all-cause mortality at 30 and 90 days after surgery.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 years and 75 years.
2. Indication for MIPD confirmed by MDT evaluation.
3. Ability to understand trial requirements and willingness to adhere to study protocols.
4. Written informed consent obtained before registration.
5. Curative-intent treatment consistent with international clinical guidelines.

Exclusion criteria

1. Requirement of partial or total pancreatectomy or other palliative procedures, or presence of distant metastases (peritoneal, hepatic, distant nodal, or other organ involvement); therefore, these patients are not candidates for MIPD.
2. American Society of Anaesthesiologists (ASA) Physical Status ≥ IV.
3. Pregnant or breastfeeding women.
4. Severe psychiatric disorders.
5. History of other malignancy.
6. Neoadjuvant chemoradiotherapy prior to surgery.
7. Body mass index >35 kg/m2.
8. History of nasopharyngeal, gastric or oesophageal surgery.
9. Preoperative gastrointestinal obstruction.
10. Contraindications to nasogastric intubation, including recent caustic ingestion, oesophageal stricture/diverticulum, or maxillofacial trauma.
11. Participation in any other clinical trials within 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

routine nasogastric tube

Active Comparator group

Description:

standard nasogastric tube placement with the tube retained postoperatively

Treatment:

Procedure: nasogastric tube decompression

routine omission of the nasogastric tube

Experimental group

Description:

avoidance of prophylactic nasogastric tube placement

Treatment:

Procedure: Omission of nasogastric tube decompression